U.S. patent number 10,548,467 [Application Number 14/728,812] was granted by the patent office on 2020-02-04 for conductive optical element.
The grantee listed for this patent is GI Scientific, LLC. Invention is credited to Frank Carter, Carl Gauger, Adnan Merchant, Scott Miller.
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United States Patent |
10,548,467 |
Miller , et al. |
February 4, 2020 |
Conductive optical element
Abstract
A device having an optical element with a conductive coating.
The device may include an optical element, a conductive material
and at least one connector. The conductive material is disposed on
at least a portion of the optical element. The optical element, for
example, may be an object lens of an endoscope or an optical
coupler. The connectors (acting as terminal(s)) are capable of
providing energy (such as electrical energy) to the conductive
material. In one aspect, the conductive material is an optically
transparent material. Advantageously, the device may allow
visualization of an object--such as body tissue or other
matter--concurrent with the application of energy to the object via
the conductive coating. This allows the user to observe the
alteration of tissue and other matter in real time as the energy is
delivered.
Inventors: |
Miller; Scott (Arlington,
VA), Carter; Frank (Wormleysburg, PA), Merchant;
Adnan (Fremonth, CA), Gauger; Carl (Kansas City,
MO) |
Applicant: |
Name |
City |
State |
Country |
Type |
GI Scientific, LLC |
Arlington |
VA |
US |
|
|
Family
ID: |
57442283 |
Appl.
No.: |
14/728,812 |
Filed: |
June 2, 2015 |
Prior Publication Data
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|
|
|
Document
Identifier |
Publication Date |
|
US 20160353978 A1 |
Dec 8, 2016 |
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N
7/022 (20130101); A61B 1/128 (20130101); A61B
1/00087 (20130101); A61B 18/14 (20130101); A61B
18/1492 (20130101); A61B 1/127 (20130101); A61B
1/00096 (20130101); A61B 18/082 (20130101); A61B
2018/00595 (20130101); A61B 18/1815 (20130101); A61B
2018/00583 (20130101); A61N 2007/0043 (20130101); A61B
2018/147 (20130101); A61B 2018/00607 (20130101); A61B
2018/00059 (20130101); A61B 2018/00982 (20130101); A61B
2018/1405 (20130101) |
Current International
Class: |
A61B
1/00 (20060101); A61B 1/12 (20060101); A61B
18/08 (20060101); A61B 18/14 (20060101); A61B
18/18 (20060101); A61N 7/02 (20060101); A61B
18/00 (20060101); A61N 7/00 (20060101) |
Field of
Search: |
;600/169,104,175
;359/512 ;204/192.29 ;606/27-52 |
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|
Primary Examiner: Fairchild; Aaron B
Attorney, Agent or Firm: Farber LLC
Claims
That which is claimed:
1. A device for use with an endoscope, comprising: an optical
coupler having a visualization section at a distal end, and an
attachment section at a proximal end for attachment to the
endoscope, the visualization section of the optical coupler
configured to cover at least some of an optical lens of the
endoscope and being capable of transmitting an optical image
through the optical coupler, the optical coupler further having a
working channel for receiving or passing an instrument, fluid or
gas, while an outer surface of the optical coupler is configured to
displace fluid, blood, debris, or particulate matter as the coupler
is advanced into a patient; an electrically conductive coating
disposed on at least a portion of the outer surface of the optical
coupler, the electrically conductive coating 1 serving as an
electrode to deliver energy to tissue adjacent to or in contact
with the optical coupler; an insulation disposed on a portion of
the electrically conductive coating, the insulation material having
an opening for receiving an instrument; and at least one connector
configured to provide energy to the conductive coating to create a
tissue effect, wherein the tissue effect is a member selected from
the group consisting essentially of desiccating, denaturing without
causing an ablative effect on, cauterizing, cutting, and
coagulating tissue, as energy is transmitted across the conductive
coating to tissue, and wherein the conductive coating is configured
for receiving energy from the connector and transmitting energy to
tissue disposed adjacent to or in contact with the conductive
coating; wherein the device allows real-time visualization of the
tissue concurrent with the application of energy to create the
tissue effect on the tissue with the conductive coating; wherein
the optical coupler is configured to prevent contact of fluid,
tissue, debris or particulate matter with the optical lens of the
endoscope.
2. The device of claim 1, wherein the optical coupler is configured
to be integrally mounted on a distal end of the endoscope.
3. The device of claim 2, wherein the optical coupler fits over the
distal end of the endoscope.
4. The device of claim 1, wherein the electrically conductive
coating is at least partially transparent.
5. The device of claim 4, wherein the electrically conductive
coating includes a conductive oxide.
6. The device of claim 5, wherein the conductive oxide is selected
from the group consisting of: a titanium conductive oxide and an
aluminum conductive oxide.
7. The device of claim 1, wherein the connector is configured for
connection to a power source.
8. The device of claim 7, further comprising the power source.
9. The device of claim 1, wherein the optical coupler is at least
partially transparent.
10. The device of claim 1, wherein the electrically conductive
coating is configured for generating and transmitting thermal
energy to a tissue disposed adjacent to or in contact with the
conductive coating.
11. The device of claim 1, wherein the electrically conductive
coating includes at least two conductive strips in a parallel
pattern.
12. The device of claim 1, wherein the electrically conductive
coating is configured for generating and transmitting thermal
energy to limit fogging.
13. The device of claim 1, wherein the outer surface encloses at
least a portion of the visualization section to prevent ingress of
fluid, tissue, debris or particulate matter between the
visualization section and the optical lens of the endoscope.
14. The device of claim 1, wherein the outer surface passes
continuously from a first outer surface boundary of the
visualization section to a second opposite outer surface boundary
of the visualization section to prevent ingress of fluid, tissue,
debris or particular matter between the visualization section and
the optical lens of the endoscope.
15. The device of claim 1 wherein the insulating material is
substantially aligned in a longitudinal direction with the distal
opening of the working channel and configured to insulate an
instrument passing through the working channel from the
electrically conductive coating.
16. A device for use with an endoscope having a working channel
with a distal end portion, comprising: an optical coupler having a
visualization section at a distal end, and an attachment section at
a proximal end for attachment to the endoscope, the visualization
section of the optical coupler configured to cover at least some of
an optical lens of the endoscope and being capable of transmitting
an optical image through the optical coupler, the optical coupler
further having a working channel for receiving or passing an
instrument, fluid or gas; an electrically conductive coating
disposed on at least a portion of the outer surface of the optical
coupler; at least one connector configured to provide energy to the
conductive coating to create a tissue effect, wherein the
conductive coating is configured for receiving energy from the
connector and transmitting energy to tissue disposed adjacent to or
in contact with the conductive coating, wherein the working channel
has a proximal end portion configured to cooperate with the distal
end portion of the working channel of the endoscope; further
comprising an insulating material disposed on a portion of the
electrically conductive coating, wherein the insulating material is
substantially aligned in a longitudinal direction with the distal
opening of the working channel and configured to insulate an
instrument passing through the working channel from the
electrically conductive coating.
17. The device of claim 16, wherein the proximal end portion of the
working channel is configured to couple to the distal end portion
of the working channel endoscope.
18. The device of claim 16, wherein the proximal end portion of the
working channel is configured to contact a portion of the surface
of the endoscope adjacent to the distal end portion of the working
channel of the endoscope.
19. The device of claim 16, wherein the working channel has a
distal opening disposed within the visualization section and spaced
proximally from at least one portion of the electrically conductive
coating.
20. The device of claim 19, wherein a portion of the visualization
section further comprises a barrier section disposed between the
distal opening of the working channel and the electrically
conductive coating.
21. The device of claim 16, wherein the electrically conductive
coating is at least partially transparent.
22. The device of claim 16, wherein the electrically conductive
coating includes a conductive oxide.
23. The device of claim 22, wherein the conductive oxide is
selected from the group consisting of: a titanium conductive oxide
and an aluminum conductive oxide.
24. The device of claim 16, wherein the optical coupler is at least
partially transparent.
25. The device of claim 16, wherein the electrically conductive
coating includes at least two conductive strips in a parallel
pattern.
Description
BACKGROUND
Minimally and less invasive surgery, and interventional treatments,
of patients are generally safer, faster, and less traumatic to the
patient. These procedures therefore involves less inflammation,
post-operative pain, infection risk, and reduced healing time
compared to more invasive forms of surgery, including general and
open surgery.
In medical applications, less invasive approaches usually involve
either direct or remote visualization with hand or remote
instruments used for diagnosis, treatment or manipulation.
Applications include surgery using a small incision (called a
mini-thoracotomy) and direct visualization of the surgical site.
Alternatively, one or more forms of remote visualization may be
used, such as an inspection of the colon using a flexible
colonoscope or visualization of a surgical site using a
laparoscope.
When engaged in remote visualization inside the patient's body, a
variety of scopes are used. The scope used depends on the degree to
which the physician needs to navigate into the body, the type of
surgical instruments used in the procedure and the level of
invasiveness that is appropriate for the type of procedure. For
example, visualization inside the gastrointestinal tract may
involve the use of endoscopy in the form of flexible gastroscopes
and colonoscopes and specialty duodenum scopes with lengths that
can run many feet and diameters that can exceed 1 centimeter. These
scopes can be turned and articulated or steered by the physician as
the scope is navigated through the patient. Many of these scopes
include one or more working channels for passing and supporting
instruments, fluid channels and washing channels for irrigating the
tissue and washing the scope, insufflation channels for
insufflating to improve navigation and visualization and one or
more light guides for illuminating the field of view of the
scope.
Smaller and less flexible or rigid scopes, or scopes with a
combination of flexibility and rigidity, are also used in medical
applications. For example, a smaller, narrower and much shorter
scope is used when inspecting a joint and performing arthroscopic
surgery, such as surgery on the shoulder or knee. When a surgeon is
repairing a meniscal tear in the knee using arthroscopic surgery, a
shorter, more rigid scope is usually inserted through a small
incision on one side of the knee to visualize the injury, while
instruments are passed through incisions on the opposite side of
the knee. The instruments can irrigate the scope inside the knee to
maintain visualization and to manipulate the tissue to complete the
repair.
Other scopes may be used for diagnosis and treatment using less
invasive endoscopic procedures, including, by way of example, but
not limitation, the use of scopes to inspect and treat conditions
in the lung (bronchoscopes), mouth (enteroscope), urethra
(cystoscope), abdomen and peritoneal cavity (laparoscope), nose and
sinus (laryngoscope), anus (sigmoidoscope), chest and thoracic
cavity (thoracoscope), and the heart (cardioscope). In addition,
robotic medical devices rely on scopes for remote visualization of
the areas the robotic device is assessing and treating.
These and other scopes may be inserted through natural orifices
(such as the mouth, sinus, ear, urethra, anus and vagina) and
through incisions and port-based openings in the patient's skin,
cavity, skull, joint, or other medically indicated points of entry.
Examples of the diagnostic use of endoscopy with visualization
using these medical scopes includes investigating the symptoms of
disease, such as maladies of the digestive system (for example,
nausea, vomiting, abdominal pain, gastrointestinal bleeding), or
confirming a diagnosis, (for example by performing a biopsy for
anemia, bleeding, inflammation, and cancer) or surgical treatment
of the disease (such as removal of a ruptured appendix or cautery
of an endogastric bleed).
Direct and remote visualization devices, such as scopes used in
endoscopy, robotic and other medical procedures, transmit images to
the viewer in a variety of ways, through the use of image capture
elements, including (i) relay lenses between the objective lens at
the distal end of the scope and an eyepiece, (ii) fiber optics,
(iii) charge coupled devices (CCD) and complementary metal oxide
semiconductor (CMOS) sensors, as well other image capture and
transmission methods known to one reasonably skilled in the art. A
typical endoscope consists of an element which holds an image
capture element and (often) a light source that illuminates the
field of view of the scope (such as light directed by an LED or
fiber system). Frequently, a video capture system is connected to
the visualization device to display a video image on a display
monitor that can be viewed by a user during use of the
visualization device. The system may include an ability to adjust
the focus of the display through manual adjustments or an autofocus
capability in a video processor system used with the optical
imaging device.
Additional devices are used with remote visualization devices to
effect treatment or repair in medical and non-medical procedures.
For example, with medical applications, it is common to use a
separate device, such as a grasper, to manipulate and shift tissue
to obtain a different vantage point and to use a third device to
cauterize or ablate tissue if there is bleeding or disease that can
be treated effectively with this approach. These devices are often
used through a different point of access, such as a separate
incision or a port, or are used through working channels designed
into certain scopes, such as colonoscopes.
There exists a need to improve the overall visualization and
manipulation of tissue and other matter through the addition of
more therapeutic and repair capabilities for use with scopes and
other optical elements.
SUMMARY
Implementations of the present disclosure overcome the problems of
the prior art by providing a device including an optical element,
one or more conductive coatings and at least one connector area to
deliver energy to the device. The conductive layer coating may be
at least partially optically transparent. It may include a
conductive oxide, such as a titanium oxide or an aluminum oxide, or
other conductive materials.
The connector area may be configured for connection to a power
source. The connection to the power source may be part of the
device. Also, the device may connect to a catheter (such as by a
flex transistor or wire), cord or other element which connects to
the connector and the power source. The power source may be part of
the device. Power sources may include an electrical energy
generator, an electrosurgical generator, a coblation generator, an
argon gas generator, an ultrasound generator, a plasma generator or
any other form of generator or other power source (including a
battery) which can make and transmit energy to or across an optical
element or a conductive coating.
The device may be removably placed on a remote visualization
device. The device may also be designed as a permanent element of a
remote visualization device, such as a scope.
The optical imaging element may be configured to shed fluid, debris
and particulate matter, to remain distant from tissue or other
matter, or to contact tissue or other matter, and to manipulate and
shift the tissue or other matter, including manipulation,
reorientation conforming the tissue to a desired shape or
dissection. The conductive coating may be configured to generate
sufficient energy to alter the tissue or other matter. The
conductive coating or coatings may be applied to the device to
create a single electrode to alter the tissue or other matter. The
conductive coatings may also be applied in multiple patterns on the
device, to create multiple electrodes to alter tissue or other
matter in more than one way. Tissue or matter alteration may, for
example, include ablation, coblation, cauterizing, shaping,
sealing, dissecting, debriding, resecting, cutting and coagulating
tissue, evaporating blood or fluid, activating and curing glues and
other chemicals or formulations activated by energy and other
results associated with the delivery of energy to manipulate or
alter matter. An area of the conductive coating may be at least
partially optically transparent. The optically transparent areas
may be overlapping and positionable on tissue and other matter
being manipulated and energized. The conductive coating may have a
thickness of half a micron or less or such other thickness to
create a specific tissue or matter alteration with the given power
source and the intended application. The conductive coating may be
uninsulated, or may be partially insulated or fully insulated
through another material, including one or more dielectric coatings
or materials.
The conductive coating may be configured to convert a power source
to one or more forms of energy for the alteration of tissue or
other matter, including monopolar energy, bipolar energy, argon gas
energy, coblation energy, plasma energy, thermal energy,
ultrasound, focused ultrasound or other forms of energy which can
be transmitted across or through a conductive coating to alter
tissue or matter. One or more biocompatible materials and any other
materials reasonably suitable may be selected or configured to
facilitate adherence of the conductive coating and the overall
performance of the device.
The optical coupler and/or its connector and power source may have
one or more feedback elements for determining the degree of
alteration of tissue or matter. These feedback elements may include
one or more temperature sensor(s), thermocouple(s), or other
elements for the measurement of the alteration, impact or effect of
one or more forms of energy when applied to tissue or other
matter.
In another implementation, a method includes contacting at least a
portion of the tissue or matter with an optical element; applying
energy to a coating on the optical element and altering the portion
of the tissue or matter. The tissue or matter is altered by
conducting energy onto or through the portion of the tissue or
matter using the coating on the optical element as an electrode to
deliver energy.
Altering the tissue or other matter may include heating,
cauterizing, shaping, sealing, dissecting, resecting, debriding,
cutting, coapting, coagulating, coblating, ablating or other
manipulation involving contact of the tissue or matter with the
energy delivered through or across the coating. Applying energy may
include applying a bipolar electrical energy through or across a
surface of the optical element. Contacting the tissue or matter may
include coapting the tissue or matter, coagulating, sealing a
vessel of the tissue or other manipulation involving contact of the
tissue or matter with the energy delivered by the coating on the
optical element.
One or more of the coatings used on the optical element may have
different water contact angles to facilitate different performance
elements with the optical element, including coatings with water
contact angles creating hydrophilic performance, hydrophobic
performance and super hydrophobic performance. One or more of the
coatings may also have anti-reflective properties to reduce or
minimize reflection of light in the field of view of the scope and
other variants of the coatings may have anti-scratch and other
hardness properties to protect the optical element. The coatings
may also be conductive and may be transparent.
Embodiments of the optical element may include the ability to
irrigate the tissue or matter and the ability to inject one or more
drugs, glues or other compounds into a targeted area for energizing
and manipulation by the device. In another aspect, the scope is a
means for viewing within the body.
One embodiment includes a device comprising: an optical element; a
conductive material disposed on at least a portion of the optical
element; and at least one connector capable of providing energy to
the conductive material. In another aspect, the optical element is
integrally mounted on a distal end of a scope. The optical element
may be a lens with the portion being an outer, distal surface of
the lens. And, the scope may be a means for viewing within the
body.
In another aspect, the connector is configured for connection to a
power source. The conductive material may be at least partially
transparent. And, the device may additionally include a power
source. For example, the power source may be selected from the
group consisting of: an electrical energy generator, an
electrosurgical generator, a coblation generator, an argon gas
generator, an ultrasound generator, cyrogenerator and a plasma
generator.
Another embodiment includes an assembly comprising: an image
capture device having a viewing end; a positioning assembly
supporting the viewing end; a conductive surface on the viewing
end, the conductive surface positioned and configured to conduct
energy over the viewing end; and a power source connection
configured to supply the energy to the conductive surface. The
positioning assembly may include an elongate member configured for
insertion through restricted openings. The positioning assembly may
also include controls coupled to an end of the elongate member
opposite the viewing end.
The image capture device may be configured to transmit fluid to the
viewing end. The image capture device may, for example, include a
working channel. And the working channel may be configured to
transmit fluid.
In another aspect, the conductive surface may be optically
transparent. And, the conductive surface may be able to overlap or
conform to the tissue.
The conductive surface may be connected to the power source by a
second conductive surface, such as a platinum surface.
Advantages of the implementations include (i) improved
visualization in fluid, debris and blood, (ii) the ability to turn
the scope into a therapeutic device by delivering energy to a
target area through the optical element on the scope, eliminating
the need to engage in a separate instrument exchange to delivery
energy to tissue or other matter, (iii) the ability to provide lens
anti-fogging capability, (iv) the ability to control energy
delivery to treat narrow to broader areas of matter and tissue
without missing a targeted area because of the ability to maintain
visualization throughout the application of energy, (v) the ability
to use the working channel in certain variants of the device to
deliver a complementary device such as a grasper while maintaining
the ability to delivery energy at any time concurrently, and (vi)
other benefits including improvement of procedures in medical
applications such as in diathermy, electrocauterization,
electrosurgery, biopsy, ablation, coblation, fogging reduction, as
well as improvements in non-medical applications such as pipeline
inspections and repairs using remote visualization. These and other
features and advantages of the implementations of the present
disclosure will become more readily apparent to those skilled in
the art upon consideration of the following detailed description
and accompanying drawings, which describe both the preferred and
alternative implementations of the present disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 shows a cross-sectional side-elevation view of a device of
one implementation of the present invention including an optical
coupler attached to the distal end of an endoscope;
FIG. 2 shows a cross-sectional side-elevation view of the optical
coupler of FIG. 1;
FIG. 3 shows a rear, sectional elevation view of the optical
coupler of FIG. 1;
FIG. 4 shows another cross-sectional view of the device of FIG.
1;
FIG. 5 shows a cross-sectional view of a device of another
implementation of the present invention;
FIG. 6 shows another cross-sectional view of the device of FIG.
5;
FIG. 7 shows another cross-sectional view of the device of FIG.
5;
FIGS. 8A, 8B and 8C show a cross-sectional view of a device of
another implementation of the present invention;
FIGS. 9A and 9B show a cross-sectional view of a device of another
implementation of the present invention;
FIG. 10 shows a cross-sectional view of a device of another
implementation of the present invention;
FIGS. 11A, 11B and 11C show a cross-sectional view of a device of
another implementation of the present invention;
FIG. 12 shows a schematic diagram of a device of another
implementation of the present invention; and
FIG. 13 shows another implementation of the present invention with
a catheter providing energy from a power source to a connector in
the device.
DETAILED DESCRIPTION
Implementations of the present disclosure now will be described
more fully hereinafter. Indeed, these implementations can be
embodied in many different forms and should not be construed as
limited to the implementations set forth herein; rather, these
implementations are provided so that this disclosure will satisfy
applicable legal requirements. As used in the specification, and in
the appended claims, the singular forms "a", "an", "the", include
plural referents unless the context clearly dictates otherwise. The
term "comprising" and variations thereof as used herein is used
synonymously with the term "including" and variations thereof and
are open, non-limiting terms.
The inventors have observed that despite the many benefits
associated with using image capture devices to improve
visualization, including remote visualization, to diagnose and
treat patients in a medical context or, separately, to inspect and
fix conditions in non-medical applications, there still are
significant issues with these technologies where improvement is
needed. Image capture elements quickly become clouded with fluid,
debris and particulate matter which obscures visualization. In
addition, image capture elements may be dependent on instruments
and other elements to provide therapy and to modify, manipulate and
repair matter.
In non-medical applications, less invasive inspection and repair of
remote areas and defects in non-medical settings, whether involving
a sewer trunk line, a hydraulic line, an oil pipeline, a gas line
or other non-medical areas in which inspection and/or repair can be
obtained with less disruption and intrusion, is generally superior
to opening up the area more invasively to inspect and repair.
In non-medical applications, direct visualization may be achieved
through the use of small ports. For example, by drilling a hole
into a pipeline to inspect the line at a specific point. Another
example is the use of a borescope to remotely navigate and advance
through the pipeline to visualize the area of inspection for
possible remote repair.
With non-medical applications, such as oil pipeline inspection,
robotic arms with grasping and articulation capability are used
with the remote visualization device to diagnose and repair.
Remote visualization devices and associated elements are also
common to non-medical scopes used for remote visualization
including rigid and non-rigid borescopes, videoscopes, flexoscopes,
fiberscopes and other scopes used for remote visualization in
non-medical applications.
Generally, the inventors have found that these instruments need to
be advanced, retracted and exchanged through incisions, ports,
working channels or other points of access. This approach means the
correct instrument is not always readily available when needed. For
example, when performing a laparoscopic surgery case, a blood
vessel may be cut and a bleed occur, while the physician is engaged
in fine dissection of tissue to access a treatment point. The
physician may not have a cautery or vessel sealing instrument in
one of the ports used to advance and retract instruments in the
patient for treatment. When this occurs, the bleed will continue
while the physician retracts one of the instruments and inserts a
cautery device or a vessel sealing device (called a device
exchange) to try and then find the bleed and stop it. Due to the
time it takes to complete the device exchange, the bleeding area
may become filled with blood, obscuring the location of the bleed.
Further, during this time, the scope may become covered with blood,
debris or other fluid, or may fog causing additional issues that
complicate finding and treating the bleed.
Similar limitations arise with scopes that have working channels.
For example, when performing a colonoscopy and excising a
pre-cancerous polyp to diagnose whether cancer is present, a vessel
may inadvertently be cut, causing a lower gastrointestinal bleed.
To treat the bleed, the physician must perform an exchange of
instruments, withdrawing the device out of the working channel of
this long, flexible scope (200 centimeters long) and inserting and
advancing a cautery device down the working channel of the scope.
The location of the scope and the bleed must then be confirmed (as
the scope may shift) and then cautery is attempted to address the
bleed. This effort may be hindered by fluid, debris and blood which
obscures the scope's visualization. In addition, the application of
cautery is very limited. This is because the cautery device can be
restricted to no wider than the diameter of the working channel in
the scope, which is typically between two and three millimeters.
Hence, the cautery lesion from current devices is usually only a
few millimeters wide, necessitating multiple cautery attempts to
treat longer or wider or uneven bleeding areas with current
technology.
This same set of issues and other issues apply with other scope
applications, including the treatment of upper gastrointestinal
bleeds. Further, other issues and limitations apply with scopes
that do not have a working channel, but must be advanced some
distance from the user. For example, such issues occur in
borescopes in non-medical applications and certain ear, nose and
throat medical applications. These issues also apply to other
applications that depend on a scope for visualization, including
robotic navigation and robotic surgery and treatment.
Implementations of the present disclosure overcome the problems by
providing a device having an optical element with a conductive
coating. The device 11 of one implementation, for example, as shown
in FIG. 1, comprises an optical element 10, a conductive material
302 and at least one connector 300. The conductive material 302 is
disposed on at least a portion of the optical element 10. The
optical element, for example, may be an object lens of an endoscope
110 or an optical coupler. The connectors (acting as terminal(s))
300, 300a, 300b are capable of providing energy (such as electrical
energy) to the conductive material 302. In one aspect, the
conductive material is an optically transparent material.
Advantageously, the device 11 allows visualization of an
object--such as body tissue or other matter 200--concurrent with
the application of energy to the object via the conductive coating.
This allows the user to observe the alteration of tissue and other
matter in real time as the energy is delivered. For example, the
device 11 can provide electrical energy via the transparent
conducive material 302 to cauterize the tissue 200 at the same time
the tissue is being directly viewed through the endoscope 72 and
the optical element on the endoscope.
As shown in FIG. 1-4, in embodiments, the optical element 10 may be
a type of optical coupler that includes a visualization section 12
at a distal end 14 and an attachment section 46 at a proximal end
48. The optical coupler 10 is configured for attachment, via the
attachment section 46, to a remote visualization device, such as an
endoscope 72. In embodiments, the optical coupler 10 is comprised
of a transparent material, at least a portion of which may cover
the optical area of the underlying endoscope 72 to keep it clear of
obscuring debris in the body. Also, the outer surfaces of the
optical coupler 10 can displace fluid, blood, debris and
particulate matter on tissues being inspected by the endoscope 72.
Additional details of such optical couplers are disclosed in U.S.
Patent Application Publication No. 2013/0110097 filed Sep. 17,
2012, which is hereby incorporated herein by reference.
Referring again to FIG. 1, the visualization section 12 includes a
distal, outer surface 16 spaced apart from a proximal surface 22.
In embodiments, at least a portion of the visualization section 12
covers some or all of the optical area of the endoscope 72. The
outer surface 16, in FIG. 1, has a rounded, convex shape. The outer
surface 16, for example, curves continuously from a first outer
side boundary 18 across to a second opposite outer side boundary 20
of the visualization section 12. In embodiments, the outer surface
may also be convex but off-centered, concave, flat, or positioned
at an angle, to the optical lens of the endoscope. For example, the
outer surface may be positioned at an angle slopping away from or,
alternatively, sloping to the optical lens of the endoscope. A
healthcare worker may advance the outer surface 16 into contact
with the tissue or other matter 200 and still maintain
visualization because of the design of the optical coupler. In
addition, the healthcare worker, by making contact with the tissue
or other matter with the optical coupler on the scope, is able to
displace fluid, blood, debris and particulate matter from the field
of view. This provides a better view of the underlying tissue or
matter for assessment and therapy, including the delivery of energy
through this device. The shape of the outer surface 16 may be
a-traumatic.
Also, in other embodiments, the device may have one or more
channels to enable the passing of instruments through the scope and
the device or to provide irrigation or insufflation, or to expose
the light guides of the scope to alter the performance of light in
certain environments. For example, these channels may be hollow and
pass through the outer surface of the device. The channels may also
be self-sealing and therefore not pass all the way through the
outer surface of the device to seal the channel when the channel is
not in use. In other embodiments, more than one channel may be
present. One channel may align with the working channel of the
scope and the device, allowing for the passing of instruments.
Another channel may allow fluid and air to emit from the scope and
pass through the device. A third channel may redirect fluid from
the fluid water on the scope to the working channel in the device
and out beyond the outer surface of the device.
The visualization section 12 can be formed from a range of
materials that provide improved visualization of objects for the
endoscope 72. For example, the visualization section may be formed
of a transparent material capable of transmitting an optical image
of the surface area. While any type of (at least partially)
transparent material may be used, materials that adhere well (and
stay adhered) to the conductive material 302 are particularly
desirable. Particularly well-suited are materials that have an
attractive index of refraction and level of light transmission.
Also desirable is a stability when used with energy applications to
minimize the impact of the substrate on the conductive materials
and the impact of the energy delivery on the optical performance.
For example, polycarbonate materials are a well-suited material for
the visualization section because of polycarbonate's index of
refraction and performance across various temperature ranges.
Additional materials include acrylic, polystyrene, cyclic olefin
copolymer, polyetherimide, glass, silicone and other optical
materials. These materials provide a combination of a relatively
low index of refraction, high light transmission and appropriate
temperature performance, including insulation properties and
relatively low levels of thermal expansion when used with the
application of various forms of energy.
In other embodiments, a device using more than one material may
connect the materials through glue or other chemical bond, molding
the materials together, over-molding one material on the other
material, placing a mechanical connector between the materials, or
over the materials, or a combination thereof. Connections may also
be made by coating one material onto another, screwing one material
on to the other, or other ways of connecting one material to
another wherein at least one of the materials is a substrate for a
conductive coating.
The term "transparent" as used herein is not always limited to
optically transparent. Instead transparent may include the ability
to or characteristic of passage of energy waves, including infrared
and/or ultraviolet rays. Transparent also need not be limited to
perfectly transparent and instead could refer to some ability to
facilitate or allow passage of light rays (e.g., translucent).
Alternatively, the coupler 10 may not be formed of a transparent
material and in embodiments can be made from one or more materials
suitable for the particular remote visualization application. In
embodiments, for certain applications, the coupler may serve as a
support and applicator for the conductive material 302 with either
limited or no ability to improve visualization.
As shown in FIG. 4, the attachment section 46 may include a
cylindrical wall 50 extending from the proximal end 48 of the
optical element 10. Generally, the attachment section 46 is
configured to mate with and secure the visualization section 12 to
the end of the endoscope 72 or other optical imaging device. To
this end, the cylindrical wall 50 is sized to define a hollow
cylindrical opening 70 for a press or other secure fit onto the
distal end of the endoscope 72. It should be noted that the
attachment section 46 may also include other structure to
facilitate attachment and/or may be secured by welding, adhesive,
screwing, mechanical connectors, interference between one or more
materials and the optical imaging device, or such other form of
connection between the device and the remote/optical imaging
device. Also, the attachment section 46 need not have a cylindrical
shape but instead can be formed to match the distal end shapes of
various optical imaging devices or remote visualization devices.
Or, the attachment section may be shaped to facilitate other
functions of the device, including shaping the sides and distal end
to conform to and manipulate tissue and matter more effectively.
Shapes and materials may be selected to make the device less
traumatic when contacting tissue and other matter. The
visualization section of the device could also be integrated into a
remote visualization device.
As shown in FIGS. 1 and 4, the endoscope 72 includes a sheath 76
having a distal end and supporting an optical assembly. The sheath
76 is a generally elongate member configured to enter and extend
through passageways to provide remote visualization in the body and
other passages. In some embodiments, endoscopes include some form
of positioning assembly (e.g., hand controls) attached to a
proximal end of the sheath 76 to allow the operator to steer the
scope. In other embodiments, the scope is part of a robotic element
that provides for steerability and positioning of the scope
relative to the desired point to investigate and focus the scope.
The sheath 76 also includes a distal end 74, as shown in FIGS. 1
and 4, extending into the cylindrical opening 70 of the optical
coupler 10.
The sheath 76 may include one or more openings or lumens extending
there-through for various purposes. For example, as shown in FIGS.
1-4, the sheath 76 defines a first lumen 100, a second lumen 102
and a third lumen 104. Each lumen extends from the proximal end to
the distal end 74 of the sheath 76. The first lumen 100 may, for
example, provide a passageway where a light guide 106 can be
positioned in for transmitting light toward distal end 74. The
second lumen 102 may provide a passageway to contain a remote
visualization lens, camera, sensor, fiber or other element 108 for
carrying the visual information back up to the proximal end of the
sheath 76. The third lumen 104 may provide a passageway through
which additional instruments, such as a wire, a catheter, biopsy
forceps, guide wire, or other instrument 202, can be extended to
the tissue or other matter 200.
As mentioned above, the sheath 76 in the embodiments of FIGS. 1-4
provides access for the optical assembly. In some embodiments, the
optical assembly includes the light guide 106, and the image
capture element 108, and object lens 110. As also mentioned above,
the light guide 106 may transmit light from the proximal end of the
sheath 76 to the distal end to illuminate the body tissue 200. The
object lens 110 is positioned at the distal end of the optical
fiber 108 and is configured to direct and focus the reflected light
back to the distal end of the optical fiber. Generally, the object
lens 110 can be any optical device that can transmit and refract
light, including compound lenses which include an array of lenses
with a common axis.
As shown in FIG. 1, upon securing the attachment section 46, the
cylindrical wall 50 extends over an outer surface 78 of the distal
end 74 of the sheath 76. And, the proximal surface 22 abuts an end
surface 80 on the distal end of the sheath 76. Also, the third
lumen 104 is aligned with a hollow instrument receptacle 40 defined
in the visualization section 12 of the optical coupler 10.
As shown in FIG. 1-4, the conductive material 302 may be applied in
a variety of configurations to create one or more electrode
designs, depending on the desired effect with tissue and other
matter. The electrode designs may be varied to suit the needs of
other applications, such as inhibiting fogging of the remote
visualization element or creating a combination of capabilities,
such as a visualization element that can be warmed intermittently
or continuously to inhibit or prevent fogging. An electrode design
may also address the ability of the conductive material 302 to
rapidly increase the energy delivery when needed to contact and
cauterize or ablate tissue or other matter.
Heating an optical lens component with a conductive coating allows
for continuous heating to prevent a significant temperature
differential at the end of the scope or optical element. (The
distal end is where the camera is often located and where the
fogging can be a problem.) The temperature difference can create
fogging, obscuring visualization through the scope or optical
element. In addition the materials of the optical coupler (for
example, such as silicone and polycarbonate) have insulation
properties that facilitate antifogging. Anti-fogging can be
accomplished for example by heating the optical element to about
body temperature. Without being bound by theory, the inventors
believe that the temperature difference at the distal end of the
scope can range from about 95 degrees to 110 or even 120 degrees
Fahrenheit, particularly if certain heat generating instruments are
used, such as a harmonic scalpel, which raises the temperature
around the end of the scope. Generally, then antifogging
applications are lower power and temperature than cautery or other
tissue modification temperatures.
In some embodiments, the conductive material may be in the form of
a layer, strip, particle, nanoparticle or other shape applied in
some discrete, continuous or intermittent pattern and in various
combinations thereof. Variations in the shapes or patterns of
application of the conductive material are possible within the
capabilities of adding one material to another by adhering or
combining the coating and other materials to achieve a desired
result.
The conductive material can comprise a transparent conductive oxide
(TCO), a conductive metal such as platinum, a polymer, or an
organic semiconductor or such other materials able to conduct or
transmit energy across the device. The term "layer" refers to at
least some area of the conductive material 302 having a relatively
uniform thickness and/or the method of application of the
conductive material 302. For instance, the conductive material may
be formed or applied through dipping, deposition coating, spraying,
sputtering, ultrasonic application, brushing, painting, or such
other application of the conductive material able to form a layer
or other pattern on the intended substrate. In some embodiments,
the conductive material may be of a uniform material thickness. In
other embodiments, the conductive material may have a varying
thickness. No part of the conductive material 302 need be of an
exact thickness--it could vary continuously throughout. Instead,
material thickness can be varied depending on the intended
electrode function, such as the target level of resistance (and its
variations) across the coating for the specific application.
Further, the conductive material 302 may be applied to form
particular shapes (other than a layer) meant to apply energy in
different patterns and densities to matter. Also, the conductive
material 302 may be applied in a non-layer like manner, such as by
being formed in a mould and then adhered, welded or otherwise
attached to the optical element. Again, the shape of the conductive
material 302 instead may correspond to the desired pattern of
energy application by the conductive material, including a specific
electrode design involving the conductive material and connectors
to the conductive material 300.
In embodiments, the conductive material layer is applied to the
distal end 14 of the optical element so that it extends over a
portion of the visualization section 12. In one implementation, the
portion of the visualization section 12 covered by the conductive
material includes the entirety of the distal, outer surface area 16
of one side of the visualization section. However, the portion of
the visualization section may include only a portion of the surface
area of one side of the visualization section or may include one or
more gaps between multiple applications of the conductive material
layer, depending on the desired electrode design and desired
result. For example, the conductive material 302 may only cover an
area within the field of view of the objective lens 110 of the
endoscope 72 or may be applied in part of the field of view or even
be outside of the field of view. In other alternatives, the
conductive material 302 may be applied in a pattern (strips,
stripes 302a (FIG. 2), dimples, voids, undulations, curves,
circles, semicircles), irregular, and such other approaches to
create an electrode for an intended result applying energy with the
device 200.
As shown in FIG. 1-4, the device 11 may also include one or more
connectors 300 to provide energy to the conductive material. The
connectors, in this implementation, include a first positive
terminal 300a and a second negative terminal 300b. Electrical
current flows from the positive terminal, through the conductive
material 302 (energizing the conductive material) and out through
the negative terminal.
The terminals can themselves be comprised of inert electrodes such
as graphite (carbon), platinum, gold, and rhodium. Additionally the
terminal may comprise copper, zinc, lead, and silver, or aluminum,
or the conductive material or any other material known to one
skilled in the art to be appropriate for transmitting energy. The
wires 304 or other means of power transmission connect the
electrode to a power cable (not shown) and may be embedded within
the sheath 76 of the endoscope 72 and run parallel and close to the
hollow instrument receptacle 40.
Alternatively, the wires or other means of power transmission may
pass through (not shown) the visualization section in the
instrument receptacle 40. The wires may also be delivered in
another alternative manner, including inductive transmission of
current to the device or to a battery embedded in the device. Power
may also be supplied by current from a battery, a catheter, a
cable, radio waves or other power transmission devices or methods
capable of extending a distance to a terminal or connector.
FIG. 13, for example, shows an energy catheter 500 configured to
extend through a channel of a delivery catheter. The energy
catheter includes a connector 502 at its distal end. An elongate
body of the energy catheter 500 defines an irrigation channel 506.
The energy catheter connects to a power and/or irrigation source
504 at its proximal end. The energy catheter 500 is configured for
extension through the scope and into the working channel 508 of the
optical coupler 10. Extension continues until the connector 502
abuts and/or otherwise mates or connects with corresponding
contacts or terminals 300 communicating with the working
channel.
The terminal or terminals 300 may be any device (including radio
waves, induction or other wireless connection) that delivers energy
of some kind to the conductive material 302. The conductive
material itself, in the case of wireless excitation or extension of
the conductive material into a shape for mating or communicating
with an energy generator (or other power source) for example, may
form or include the terminals 300.
It should be noted that the optical element 10 (in the form of a
coupler, lens, coupler or other attachment, or integrated as part
of the scope) can be used with a range of different scopes or other
image capture devices. The term coupler here refers more generally
to an optical element attached over the scope or integrated as part
of the scope--which may include one integrally formed or attached
to the scope or other technology for capturing and transmitting an
image. The term "coupler" as used herein refers to a separately
manufactured and/or separately, later attachable coupler, cap or
lens.
The optical element can be adapted for use with optical capture
elements of various sizes, including, relatively large telescopes,
for example. Or, the optical element 10 can be the objective lens
of the telescope wherein the device 11 is formed by disposing the
conductive material 302 on at least a portion of the lens of the
telescope and providing at least one terminal 300 for providing
energy to the conductive material 302 on the lens. This may be
useful for example, to prevent fogging on the lens. The optical
element could also be used with, or be a portion of, a microscope
in the same fashion. Other scopes that can be used with or for the
optical element include: hydroscopes, haploscopes, culpascopes,
ecoscopes, fiberscopes, videoscope, stauroscopes, stereoscope, and
rhinoscope.
Also, the term "endoscope" refers generally to any scope used on or
in a medical application, which includes a body (human or
otherwise) and includes, for example, a laproscope, arthroscope,
colonoscope, bronchoscopes, enteroscope, cystoscope, laparoscope,
laryngoscope, sigmoidoscope, thoracoscope, cardioscope, and
saphenous vein harvester with a scope, whether robotic or
non-robotic; and also includes scopes used in non-medical
applications, such as, for example, borescopes, videoscopes,
flexoscopes, and fiberscopes, whether robotic or non-robotic and
includes any other scope disclosed herein.
The term "image capture device" as used herein also need not refer
to devices that only have lenses or other light directing
structure. Instead, for example, the image capture device could be
any device that can capture and relay an image, including (i) relay
lenses between the objective lens at the distal end of the scope
and an eyepiece, (ii) fiber optics, (iii) charge coupled devices
(CCD), (iv) complementary metal oxide semiconductor (CMOS) sensors.
An image capture device may also be merely a chip for sensing light
and generating electrical signals for communication corresponding
to the sensed light or other technology for transmitting an image.
The image capture device may have a viewing end--where the light is
captured--and the conductive surface 302 may extend over a portion
of the image capture element or may be applied away from the image
capture element to other embodiments. Generally, the image capture
device can be any device that can view objects, capture images
and/or capture video.
Although one particular implementation of the optical coupler is
described above, additional types of optical couplers may include
some type of conductive material applied thereto. For example, U.S.
Patent Application Publication No. 2012/0209074 filed Feb. 16,
2012, which is hereby incorporated herein by reference, discloses
several variations on optical elements to which the conductive
material may be applied.
For example, FIG. 5 of the present disclosure shows another
implementation of an optical element 10 attached to an endoscope
72. In FIG. 5, a portion of the outer surface 16 of the
visualization section 12 is dome-shaped, and the portion of the
outer surface of the visualization section that is dome-shaped is
within the field of view A of the endoscope 72. For the dome-shape,
the conductive material 302 may be required on an increased surface
area with smoother transitions (as compared to FIGS. 1-4, if the
entire dome is covered) or may be applied only within the field of
view A.
Generally, the dome shape may improve imaging with an increased
working space as organs can be pushed out of the field of view or
this and other shapes may be utilized to optimize the field of
view, the optical clarity, the conformance of the lens to targeted
tissue or other matter. Other performance related reasons for
adapting shapes of the optical element include a desire for light
transmission, material adherence between shapes, navigation through
a specific area, including a target lumen.
As another example, FIG. 6 and FIG. 7 show an exemplary optical
element 10 engaging a region of a body cavity 200. First the
optical element 10 is placed in contact with a region of the body
cavity 200. Then the physician can insert a medical instrument 202
(FIG. 6) in the third lumen 104 of the sheath 76 of the endoscope
72. The medical instrument is passed through the instrument
receptacle 40 in the optical element and then the medical
instrument 202 is pierced through a barrier section 42 and the
outer surface 16 of the optical element 10 (FIG. 7 of present
disclosure). A medical procedure can then be performed using the
medical instrument on the region of the body cavity 200.
The barrier section 42 is a portion of the visualization section 12
that intervenes (prior to passage of the medical instrument 202)
between the environment and the instrument receptacle 40. In one
aspect, the barrier section may be coated with an insulating
material 310 to prevent direct contact by the medical instrument
202 with the conductive material 302. The insulating material 310,
for example, may extend from the outer surface 16 and be of the
same or greater thickness than the layer of conductive material
302. Advantageously, the insulating material 310 may prevent a
disruption of the conductivity of the conductive material 302, such
as by a metal instrument causing a short to an electrically
energized conductive material layer. Or, the insulating material
may just be a more elastic, physical guard against damage by the
medical instrument 202.
FIG. 8A shows a cross-sectional view of another implementation of
an optical element attached to an endoscope 72. This implementation
includes a biopsy forceps 61 placed through one of the endoscope
72's lumens 104 and through the optical element 10's instrument
receptacle 40.
In FIG. 8A, the jaws of the biopsy forceps 61 are being opened.
FIG. 8B is a cross-sectional view with the jaws of the biopsy
forceps closed to take a biopsy sample from the body cavity 200.
FIG. 8C is a cross-sectional view of the biopsy forceps being
withdrawn after having taken the biopsy sample.
In the implementation of FIGS. 8A-C, the optical element 10 has a
frusto-conical 10 shape with the broader base extending distally.
In this implementation, the conductive material 302 is relatively
flat and can be easily applied to a relatively flat tissue surface.
Also, the conductive material 302 may be in a layer with an opening
that is surrounded by an insulating material 310, such as shown in
FIGS. 6 and 7. As described above, this can insulate against a
short or damage by the biopsy forceps 61 to the conductive
material. Also, the electrodes 300a and 300b may extend down the
angled sides of the frusto-conical shape and may or may not be
partially or fully insulated.
FIGS. 9A and 9B show another implementation of an optical element
10 with an angled outer surface 16. For example, the optical
element 10 may be an optical coupler mounted to a borescope 77. The
optical coupler 10 has a visualization section 12 that has a first
outer boundary 515 and a second outer boundary 516. The first and
second outer boundaries 515, 516 extend outwards from the borescope
at an angle. An outer surface 514 of the coupler 10 is also angled,
such that includes a first segment 514a and a second segment 514b.
In this configuration, the conductive material layers 302 are
similarly layered.
FIG. 9B shows the optical element 10 of FIG. 9A inspecting a weld
lodged between two plates 88, 90. Advantageously, the electrodes
300 can deliver energy to the conductive layers 302 which may heat
and/or alter the angled plates 88, 90, to, for example, repair the
weld while the weld is being directly viewed by the operator.
FIG. 10 shows an optical element 10 attached to an endoscope that
has an auxiliary channel via the third lumen 104. A nozzle 943 is
provided at the distal end of the auxiliary channel 104 for
transmitting fluid, air or other matter. The optical coupler
includes a chamber 945 extending around the long axis of the scope
that can receive fluid 947 from the auxiliary fluid channel 104 and
nozzle 943. This allows the fluid 947 to pass into and through the
instrument receptacle 40 in the optical element 10. This channel
can be used to transmit fluid, including water or saline to
irrigate tissue or to rinse debris from the field of view or to
clean the outer surface of the coupler, or to transmit drugs and
other chemicals, and other matter, such as air, CO2, argon gas and
other matter to effect targeted tissue or other matter. In FIG. 10,
the conductive material 302 is applied in a layer similar to FIGS.
1-4. An opening may extend through the conductive material 302 for
aspiration of the external environment as well as applying positive
pressure to the instrument receptacle 40 when an instrument is
deployed externally.
FIG. 11A of the present disclosure is a cross-sectional view of an
optical element 10 having a concave outer surface 16 that is
attached to an endoscope 72 approaching tissue covered in blood
800. FIG. 11B shows the optical element 10 pressed against a cavity
in the tissue 200 and trapping opaque liquid 91. FIG. 11C shows
fluid from the instrument receptacle 40 flushing the trapped opaque
liquid 91. Advantageously, when the pressure of the introduced
fluid exceeds the pressure exerted by the optical element 10
against body cavity 200, the fluid 891 will flush the trapped
opaque liquid 91 from the area.
In FIGS. 11A and 11B, the conductive material 302 is applied in a
concave layer, similar to the concave outer surface 16. The
terminals 300 extend along the sides of the optical element 10 to
make contact with ends of the concave conductive material 302.
Applications of the Device and Conductive Material
The conductive material 302 of the various implementations of the
device 11 may be used to deliver many energy types and employed in
many medical and non-medical applications. Examples of such energy
types and applications are provided below for illustrative purposes
and should not be considered limiting.
As shown schematically in FIG. 12, the conductive material 302 is a
resistor and/or capacitor attached via terminals 300a and 300b and
a connector 304 and a cable 96 to a power source 94. The connector
304 may extend through the endoscope sheath 76, for example, and
into the cable 96 attached to the endoscope's proximal end. Those
connectors may connect to the power source 94 that may, for
example, be one or more forms of energy for the alteration of
tissue or other matter, including monopolar energy, bipolar energy,
argon gas energy, coblation energy, plasma energy, thermal energy,
microwave energy, ultrasound, focused ultrasound or other forms of
energy, including the generation and transmission of multiple
energy forms which can be transmitted across or through a
conductive coating to alter tissue or matter, including for
therapeutic effects. These can be delivered through direct current,
alternating current, pulsed current and other variable forms of
energy delivery.
There are many ways to deliver energy to the terminals 300 and the
conductive material 302. The cable 96 can deliver power to the
conductive material by way of the terminal 300, 300a, 300b. The
cable can access the terminals by, for example, being adjacent to
and outside of the scope or wrapped around the outside of the scope
72. Or, the cable 96 or connector 304 can be attached to an energy
delivery catheter that is passed down the working channel (e.g.,
first lumen 100) of the scope and docks with the terminals. At its
distal end, the energy delivery catheter may be connected to an
electrical terminal in the working channel of the lens 110. The
connectors 304 may also be embedded within the sheath 76 of the
endoscope 72 and run parallel and close to the hollow instrument
receptacle 40. The connectors may be comprised of flex circuits,
one or more coatings, wires, conductive springs, inductive material
for receiving and transmitting power, cables, or such other
approaches for transmitting power from a power source toward a
deliver point.
In another implementation, the electrical energy generator can
comprise a signal generator such as: a function generator, an RF
signal generator, a microwave signal generator, a pitch generator,
an arbitrary waveform generator, a digital pattern generator or a
frequency generator. An existing electrosurgical generator may be
used with the advantage that it meets standards necessary for
medical use. These generators may provide power to electronic
devices that generate repeating or non-repeating electronic signals
(in either the analog or digital domains). RF signal generators can
range from a few kHz to 6 GHz. Microwave signal generators can
cover a much wider frequency range, from less than 1 MHz to at
least 20 GHz. Some models go as high as 70 GHz with a direct
coaxial output, and up to hundreds of GHz when used with external
waveguide source modules. Also FM and AM signal generators may be
used.
The benefit of these different generators and others is they offer
specific forms of power for targeted applications where one form of
power has advantages over other forms. For example, when cutting
and coagulating tissue, monopolar electricity typically can cut and
coagulate through tissue more effectively than bipolar electrical
energy. But monopolar energy requires the use of a grounding pad to
avoid the arching of monopolar energy to unintentional areas.
Hence, a grounding pad can be used with a monopolar application to
affect tissue and prevent arching and subsequent electrical energy
and burns to the patient with the monopolar energy. (The ground pad
completes the circuit of the electrical energy through the
patient.)
In contrast, bipolar electrical energy has a completed circuit in
the device itself and therefore energy travels through and across
the device, affecting tissue, but not arching through the body.
With this approach, bipolar electrical energy can be very effective
for creating lesions, sealing vessels and other applications
involving targeted treatment of tissue. But, it tends to be less
effective with cutting and coagulating through tissue as an
alternative to a surgical knife because of the contained aspect of
the bipolar electrical energy. Similarly, microwave energy may be
used for certain types of ablation of tissue because of its unique
tissue effect and bipolar energy may be used for other types of
ablation. Other forms of energy, such as FM energy, may be used
because the frequency does not excite certain collateral elements,
such as nerve bundles.
A coablation generator can be used in the non-heat driven process
of surgically disassociating soft tissue by using radiofrequency
energy to excite the electrolytes in a conductive medium, such as
saline solution, to create a precisely focused plasma field.
Energized particles, or ions, in the plasma field can have
sufficient energy to break, or dissociate, organic molecular bonds
within soft tissue at relatively low temperatures, i.e., typically
between 40.degree. C. to 70.degree. C. This enables coblation
devices to volumetrically remove target tissue with minimal damage
to surrounding tissue. Coblation can also provide hemostasis and
tissue shrinkage capabilities. The amount of power delivered can be
determined by intensity of the field and can be adjusted based on
the local environmental condition.
Coblation may be used for temperature ranges typically up to
90.degree. C.
An ultrasound generator is capable of generating acoustic waves
having a frequency greater than approximately 20 kilohertz (20,000
hertz). The ultrasound waves may be conducted by the conductive
material 302 to the tissue 200. Ultrasound can be absorbed by body
tissues, especially ligaments, tendons, and fascia, or other
matter.
Ultrasound devices can operate with frequencies typically from 20
KHz up to several GHz. Therapeutic ultrasound frequency used is
typically between 0.7 to 3.3 MHz. Ultrasound energy or TENS energy
may speed up the healing process by increasing blood flow in the
treated area, decrease pain from the reduction of swelling and
edema, and gently massage the muscles tendons and/or ligaments in
the treated area.
Ultrasound may also non-invasively or invasively to ablate tumors
or other tissue. This can accomplished using a technique known as
High Intensity Focused Ultrasound (HIFU), also called focused
ultrasound surgery (FUS surgery). This procedure uses generally
lower frequencies than medical diagnostic ultrasound (250-2000
kHz). Other general conditions which ultrasound may be used for
treatment include such as examples as: ligament sprains, muscle
strains, tendonitis, joint inflammation, plantar fasciitis,
metatarsalgia, facet irritation, impingement syndrome, bursitis,
rheumatoid arthritis, osteoarthritis, and scar tissue adhesion.
The device 11 also allows a medical practitioner to perform among
others, cauterization of tissue, vessel sealing, tissue dissection
and re-sectioning, tissue shaping, tissue cutting and coagulation,
tissue ablation, and instrument heating, all at the precise
location that the practitioner is viewing. This at least partially
addresses the problem of performing aspects of endoscopic surgery
in the blind. It may also eliminate the need to exchange one device
for another to apply energy to the tissue or matter or to deflect
tissue or other matter or to engage in other manipulation while
maintaining visualization.
More specific medical applications include, among others,
application of energy to effect tissue in trauma cases,
arthroscopic surgery, spine surgery, neurosurgery, shoulder
surgery, lung tumor ablation, ablation of cancerous tissue with
bladder cancer patients, cauterization or ablate uterine tissue for
women's health issues (such as endometriosis). In these
applications (and the other applications listed herein), the device
can be used to contact tissue and then cauterize, ablate or shape
the tissue (done with coblation energy for example in shoulder
procedures), creating unique performance attributes by allowing the
physician to see the change taking place to the tissue in real time
through, for example, an optically clear lens and coating.
The device can also be used to heat an optically clear lens to
prevent fogging during applications involving a laparoscope,
borescope, videoscope or other optical capture technology.
To further elaborate on the medical applications, use of the device
in diathermy applications is a useful area, whether achieved using
short-wave radio frequency (range 1-100 MHz) or microwave energy
(typically 915 MHz or 2.45 GHz). Diathermy used in surgery can
comprise at least two types. Monopolar energy is where electrical
current passes from one electrode near the tissue to be treated to
the other fixed electrode elsewhere in the body. Usually this type
of electrode is placed in a specific location on the body, such as
contact with the buttocks or around the leg. Alternatively, bipolar
energy can be used, where both electrodes are mounted in close
proximity creating a closed electrical circuit on the device (in
this case two separate conductive material portions 302 on the
optical element 10) and electrical current passes only through or
on the tissue being treated. An advantage of bipolar electrosurgery
is that it prevents the flow of current through other tissues of
the body and focuses only on the tissue in contact or close
proximity to the electrodes. This is useful in, for example,
microsurgery, laparoscopic surgery, cardiac procedures and in other
procedures, including those with patients with cardiac pacemakers
and other devices and conditions not suitable for use with other
forms of energy.
Electrocauterization is the process of modifying tissue using heat
conduction from electric current. The procedure is used to stop
bleeding from small vessels (larger vessels can be ligated) or for
cutting through soft tissue. High frequency alternating current is
used in electrocautery in unipolar or bipolar fashion. It can be
continuous waveform (to cut tissue) or intermittent type (to
coagulate tissue). In unipolar type, the tissue to be
coagulated/cut is to be contacted with small electrode, while the
exit point of the circuit is large in surface area, as at the
buttocks, to prevent electrical burns. Heat generated depends on
size of contact area, power setting or frequency of current,
duration of application, waveform. A constant waveform (generally)
generates more heat than intermittent one because the frequency
used in cutting the tissue is set higher than in coagulation mode.
Bipolar electrocautery establishes circuit between two points to
affect tissue or other matter.
As another option, the conductive layer 302 and device 11 may be
used for thermal cautery in ranges of 50.degree. C. through
100.degree. C., or even in a range 50.degree. C. through 70.degree.
C., or at a lesser temperature if advisable, with the application
of a range of power, appropriate to the application.
Advantageously, the ability to visualize as forms of energy are
applied through the device allows for the precise delivery of
energy, including changing the level of energy and resulting
temperature, using power settings appropriate to the specific
application, applying energy over a longer period of time to
broaden coverage, applying energy across multiple electrodes for
multiple effects, and the ability to stop the process with more
confidence that the tissue or other matter has been satisfactorily
transformed. (This advantage of course applies to other
applications of the device 11--real time visual monitoring of
energy application allows for more precision application.)
The optical element 10 may also be beneficial in non-medical
applications. Implementations of the optical element can be
attached to the distal end (objective lens) of a borescope or
attached to micro or conventional video cameras, inspection scopes,
or still cameras or any other visualization device that would
benefit from improved visualization in fluid, debris and/or blood
and delivery of energy. This allows improved viewing and the
ability to make repairs inside pipes, holding tanks, containers,
hydraulic lines and other circumstances where visualization may
otherwise be impaired, including when fluid is opaque, such as
petroleum products, sewerage, food products, paint. Biologic drug
manufacturing, pharmaceutical products and other applications would
benefit from this innovation, as well, eliminating the need to
empty the pipes or containers (e.g., oil tanks) or open up the
lines to inspect.
The size of the optical element or the amount of flexibility can be
scaled for specific applications, for example, displacing large
volumes of fluid when examining large areas. The shape of the
optical element can be generally flat, convex (with varying levels
of curvature), angled, sloped, stepped, or otherwise shaped for
specific tasks. For example, the optical element may be shaped as a
square, or as an angular shape to displace opaque fluids in the
corners of a tank to inspect the seams. Examination of joints,
welds, seams for corrosion, pipes, flexible and non-flexible
tubular members, or cracks, surface aberrations, and other points
of inspection and repair could be performed in pipes, lines, tubes,
tunnels, and other passages.
An optical element could be used in conjunction with an image
capture element and a robotic vehicle or a robotic arm to view
remote locations. Optical components with working channels will
allow devices to be passed through an optical element to make
repairs using screws, adhesive patches, glues, chemicals, welding,
soldering and other repair and modification applications. In
embodiments, the optical element can be formed from materials that
resist acid, alkalinity, high heat, or viscosity of the fluid being
displaced by the optical element. In embodiments, the device could
be a single-use disposable device or a reusable device.
Advantageously, implementations of the device 11 provide the
ability to apply energy via the conductive material 302 in these
varied non-medical applications. The energy provided to the viewed
object may heat, alter or otherwise affect the object being viewed
by the optical element 10.
Conductive Material Compositions
The conductive material 302 may have various compositions and be
applied to the optical element 10 various ways. Examples of such
compositions and applications are provided below for illustrative
purposes and should not be considered limiting. For medical
applications, the conductive material 302 preferable can withstand
sterilization, such as by gamma irradiation, ethylene oxide, steam,
or other forms of sterilization.
The electrically conductive/responsive coating can be applied in
multiple configurations to create one or more electrodes. This
electrode can be optically clear and of various thicknesses,
including thickness of a half micron or less, and at much greater
thicknesses, depending on the intended effect with tissue or other
matter.
The conductive material can be at least partially transparent and
can comprise for example, any member of the general class of
materials known as transparent conductive oxides (TCOs), with
titanium oxide (TiO.sub.2) and aluminum-doped zinc oxide (AZO),
being two examples. It could also involve applications of other
conductive materials applied in a manner that permit visualization,
such as silver and gold nanoparticles, and other conductive
materials applied in a manner that allows for the conduction of
energy and visualization.
Optical diffraction indexes for the visualization materials include
materials with indexes of refraction that range from 1.3 to 2.3,
depending on the application, the level of light transmission
desired, the overall optical performance and other factors.
A transparent conductive oxide may comprise transparent materials
that possess bandgaps with energies corresponding to wavelengths
which are shorter than the visible range of 380 nm to 750 nm. A
film of a TCO can have a varying conductivity, for example, across
points on the surface thereof. In one aspect, the film has no or
substantially no pores, pinholes, and/or defects. In another
aspect, the number and size of pores, pinholes, and/or defects in a
layer do not adversely affect the performance of the layer in the
device. The film thickness can range from less than 1 to about 3500
nm. In embodiments, different methods of fabrication and intended
applications can lead to different thicknesses such as, for
example, films about 10, 20, 30, 40, 50, 60, 70, 80, 100, 200, 300,
400, 500, 600, 700, 800, 900, 1000, 1300, and 1500 nm thick.
The transparent conductive film can be indium tin oxide, Al or Ga
doped zinc oxide, Ta or Nb doped titanium oxide, F doped tin oxide,
and their mixtures. The oxide layer can be formed by directly
oxidizing an ultra-thin metal layer or by depositing an oxide. The
TCO material can have polycrystalline, crystalline, or amorphous
microstructures to affect the film properties, including for
example, transmittance and conductivity, among other
properties.
Biocompatible TCOs can also be used as the transparent conductive
material. These include, for example, aluminum oxide (Al2O.sub.3),
hydroxyapatite (HA), silicon dioxide (Sift) titanium carbide (TiC),
titanium nitride (TiN), titanium dioxide (TiO.sub.2), zirconium
dioxide (ZrO.sub.2). These materials may be n-doped with other
metals such as aluminum, Al, copper, Cu, silver, Ag, gallium, Ga,
magnesium, Mg, cadmium, Cd, indium, In, tin, Sn, scandium, Sc,
yttrium, Y, cobalt, Co, manganese, Mn, chrome, Cr, and boron, B.
p-Doping can be achieved with nitrogen, N, and phosphorus, P, among
others.
TiO.sub.2 can serve as a biocompatible material; it provides the
possibility to coat substrates at temperatures ranging from room
temperature to several hundreds of degrees centigrade. TiO.sub.2
has multiple different polymorphic phases that can depend on the
initial particle size, initial phase, dopant concentration,
reaction atmosphere and annealing temperature. The TiO.sub.2 films
are commonly synthesized by many methods, including sol-gel,
thermal spraying and physical vapor deposition.
Transparent conducting, aluminum doped zinc oxide thin films
(Al.sub.xZn.sub.yO.sub.z, ZnO:Al) contain a small amount (typically
less than 5% by weight) of aluminum. The underlying substrate may
have an influence on the grown structure and the opto-electronic
properties of a film of the material. Even if the substrate is
identical, the layer thickness (deposition time, position upon the
substrate) itself influences the physical values of the deposited
thin film.
A variation of the physical values from the grown thin films can
also be reached by changing process parameters, as temperature or
pressure, or by additions to the process gas, as oxygen or
hydrogen. Commonly, zinc oxides are n-doped with aluminum.
Alternatively, n-doping can be done with metals such as copper, Cu,
silver, Ag, gallium, Ga, magnesium, Mg, cadmium, Cd, indium, In,
tin, Sn, scandium, Sc, yttrium, Y, cobalt, Co, manganese, Mn,
chrome, Cr, and boron, B. The p-Doping of ZnO can be achieved with
nitrogen, N, and phosphorus, P.
Additionally, the incorporation of sub-wavelength metallic
nanostructures in TCO can result in changes to the wavelength where
the TCO becomes transparent. Embedded particles articles can also
be used to control absorption and scattering at desired
wavelengths. Other optical effects of the material can be
influenced as well including absorption, scattering, light trapping
or detrapping, filtering, light induced heating and others. The
morphology of the particles (including size, shape, density,
uniformity, conformity, separation, placement and random or
periodic distribution) can be used to engineer these effects.
The substrate of the electrode of the invention can be of any
suitable material on which the transparent electrode structure of
this invention is applied. This can include another conductive
material or a dielectric material. In one illustrative example, the
optical element 10 serves as the substrate. Other substrates
include, among others, glass, a semiconductor, an inorganic
crystal, a rigid or flexible plastic material. Illustrative
examples are silica (SiO.sub.2), borosilicate (BK7), silicon (Si),
lithium niobate (LiNbO.sub.3), polyethylen naphthalate (PEN),
polyethelene terephthalate (PET), among others.
Organic materials can also serve as the conductive material. These
include carbon nanotube networks and graphene, which can be
fabricated to be highly transparent to infrared light, along with
networks of polymers such as poly(3,4-ethylenedioxythiophene) and
its derivatives.
Polymers can also serve as the conductive material. For example,
conductive polymers such as derivatives of polyacetylene,
polyaniline, polypyrrole or polythiophenes.
poly(3,4-ethylenedioxythiophene) (PEDOT), and PEDOT:poly(styrene
sulfonate) PSS. Additionally,
Poly(4,4-dioctylcyclopentadithiophene) doped with iodine or
2,3-dichloro-5,6-dicyano-1,4-benzoquinone (DDQ) can be used. Other
polymers with n or p type dopants can also be used.
Conductive material films can be deposited on a substrate through
various deposition methods, including metal organic chemical vapor
deposition (MOCVD), metal organic molecular beam deposition
(MOMBD), spray pyrolysis, and pulsed laser deposition, dip coating,
painting, gluing or other applications suitable for appropriately
adhering the conductive materials to the given substrate for the
particular application. Fabrication techniques of TCOs include
magnetron sputtering of the film, sol gel technology, electro
deposition, vapor phase deposition, magnetron DC sputtering,
magnetron RF sputtering or a combination of both the sputter
deposition methods, ultrasonic delivery and welding. Moreover, high
quality deposition methods using thermal plasmas, (low pressure
(LP), metal organic (MO), plasma enhanced (PE)) chemical vapor
deposition (CVD), electron beam evaporation, pulsed laser
deposition and atomic layer deposition (ALD) can be applied, among
others.
A thin film, such as ALD, only a few nanometers thick can be
flexible and thus less prone to cracking and formation and
spreading of detrimental particles inside the human body or insider
the given non-medical inspection site. Also, low and high protein
binding affinity coatings can be deposited by ALD. They are
especially useful in diagnostics and in the preparative field, as
well as for surface coatings that resist bacterial growth.
Pre and post deposition processing such as processing with an
oxygen plasma and thermal treatment can be combined to obtain
improved conductive material characteristics. The oxygen plasma
might be preferable for when the substrate, or conductive material
would be affected by the high temperatures. The conductive material
film can have a wide range of material properties depending on
variations in process parameters. For example, varying the process
parameters can result in a wide range of conductivity properties
and morphology of the film.
The term "connector" as used herein should be construed broadly to
mean any structure that enables electrical or other energy
communication to the conductive coating. The term "connector" can
refer to a permanent connection (solder, gluing, twisted wires, a
conductive path with a conductive coating) or exchangeable
connectors, like a plug and harness assembly, or other way of
transmitting energy from a power source towards the conductive
coating. It need not be a physical connection all the way through
to the coating. It could, for example, connect via electromagnetic
field--such as by inductance. The term "connector" may also include
structure and/or function that allows, mediates, enhances or
otherwise facilitates a connection. A particular type of connector
is a terminal that may be, for example, an area of conductive
material provided for or capable of electrical coupling with a
power source. A terminal, for example, may be a conductive metal
layer deposed on a surface and shaped for contact with an end of a
wire on an energy supply catheter.
A "connector area" is an area where the connector can be attached,
mounted, coated, glued, affixed, adhered, layers, overlapped or can
otherwise communicate energy to the conductive coating.
A number of aspects of the systems, devices and methods have been
described. Nevertheless, it will be understood that various
modifications may be made without departing from the spirit and
scope of the disclosure. Accordingly, other aspects are within the
scope of the following claims.
* * * * *
References